Urology catheter

ABSTRACT

A urology catheter is provided that includes an elongated body extending from a proximal end to a distal end. The body defines at least one lumen. A tip has a proximal end that is disposed in abutting relation with the distal end of the body such that the body is fixed with the tip. The tip defines a lateral opening that is defined by a wall including an external radius disposed in transition with an outer surface of the tip and an internal radius disposed in transition with an inner surface of the tip. The external radius has a non-perpendicular profile with the outer surface of the tip. An expandable member has a proximal portion disposed about the body and a distal portion disposed about the tip. A method of manufacturing the urology catheter is provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 10/951,178, filed Sep. 27, 2004, which application claimspriority to U.S. Provisional Patent Application Ser. No. 60/506,403,filed Sep. 26, 2003, the entire contents of these applications beinghereby incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to medical catheters, and moreparticularly to a urology catheter including an advantageous tipconfiguration and related method of manufacture.

2. Description of the Related Art

As is known, urinary catheters may be employed to transport urinecollected in the bladder out of a patient via the urinary tract. Forexample, urinary catheters such as Foley catheters have a shaftincluding a drainage lumen that communicates with drainage eyes disposedadjacent a distal end thereof. An inflatable balloon is disposedadjacent the distal end of the shaft. During placement, the distal endof the shaft is passed through the patient's urethra until the balloonand drainage eyes are located in the patient's bladder. The balloon isinflated through an inflation lumen to retain the catheter in thebladder. Urine may drain through the drainage eyes and drainage lumen,which is in communication with a proximal end of the catheter. Theproximal end of the catheter is connected to a receptacle for collectionof urine.

Various known urology catheters may be produced with a liquid injectionmolded tip that is attached to the catheter shaft. Typically, the draineyes of the urinary catheter are formed via a punching operation. Thispunching operation, however, can disadvantageously result in jaggededges around the eyes and an inconsistent eye size. Other known urinarycatheters may include molded drain eyes.

These known manufacturing apparatus and techniques suffer from variousdrawbacks. For example, the size of the drain eye may be limiteddisadvantageously resulting in inferior drainage or rapid blockage dueto encrustation. Alternatively, due to manufacturing constraints, thesize of the drain eye may have to be increased to accommodate themanufacturing apparatus. An increase in size of the drain eye may causethe tip to become undesirably flexible, disadvantageously resulting indifficult insertion with the body due to tip deflection.

Therefore, it would be desirable to have a urology catheter including anadvantageous tip configuration and related method of manufacture thatimproves drainage characteristics, avoids encrustation and enhancesstiffness to facilitate tip insertion with a patient. Desirably, a draineye of the urology catheter is defined by an external radius and aninternal radius of the tip. It would be highly desirable if the urologycatheter and its constituent parts are easily and efficientlymanufactured and assembled.

SUMMARY

Accordingly, a urology catheter is provided that includes anadvantageous tip configuration and related method of manufacture thatimproves drainage characteristics, avoids encrustation and enhancesstiffness to facilitate tip insertion with a patient to overcome thediscussed disadvantages and drawbacks of the prior art. Desirably, theurology catheter includes a drain eye that is defined by an externalradius and an internal radius of the tip. Most desirably, the urologycatheter is easily and efficiently manufactured and assembled.

In one particular embodiment, a urology catheter is provided, inaccordance with the principles of the present disclosure. The catheterincludes an elongated body extending from a proximal end to a distalend. The body defines at least one lumen. A tip has a proximal end thatis disposed in abutting relation with the distal end of the body suchthat the body is fixed with the tip. The tip defines a lateral openingthat is defined by a wall including an external radius disposed intransition with an outer surface of the tip and an internal radiusdisposed in transition with an inner surface of the tip. The externalradius has a non-perpendicular profile with the outer surface of thetip. An expandable member has a proximal portion disposed about the bodyand a distal portion disposed about the tip. The lateral opening may beformed by a molding process. The tip and the body may be fabricated froma material including silicone.

Alternatively, the body can define a first lumen and a second lumenconfigured for fluid flow to inflate the expandable member. In analternate embodiment, an expansion device is disposed within the bodyadjacent to the expandable member.

In another alternate embodiment, the catheter includes a body defining alongitudinal axis and having a distal end. A tip having a proximal endis disposed in abutting relation with the distal end of the body suchthat the body is fixed with the tip. An expandable member having aproximal securing portion is disposed about the body. A distal securingportion is disposed about the body and the tip. The distal securingportion of the expandable member is bonded over an abutment region ofthe body and the tip. The distal securing portion of the expandablemember can be adhesively bonded over a region of fixation between thebody and the tip.

In another alternate embodiment, the catheter includes an elongated bodydefining a longitudinal axis and extending from a proximal end to adistal end. The distal end defines a planar face that has asubstantially perpendicular orientation relative to the longitudinalaxis. The body further defines a first lumen and a second lumen. A tiphaving a proximal end defines a planar face. The planar face of the tipis disposed in abutting relation with the planar face of the body suchthat the body is secured with the tip. The tip further defines a centrallumen that is in fluid communication with the first lumen. The tip has alateral opening that is defined by a wall having a radius of curvature.The radius of curvature includes an external radius disposed intransition with an outer surface of the tip and an internal radiusdisposed in transition with an inner surface of the tip. A cuff having aproximal securing portion is disposed about the body and a distalsecuring portion is disposed about the tip. The distal securing portionof the cuff is bonded over an abutment region of the body and the tip.The cuff defines an inflation cavity with an outer surface of the bodythat is in fluid communication with the second lumen. A cross sectionalarea of the central lumen maybe greater than a cross sectional area ofthe first lumen.

In another particular embodiment, a method of manufacturing a catheterhaving a body and a tip is provided, in accordance with the principlesof the present disclosure. The method includes the steps of providing amold that defines a mold cavity and a post cavity that communicates withthe mold cavity, the post cavity defines a predetermined transitionconfiguration; providing a pin having a post extending therefrom, thepost cooperating with the predetermined transition configuration of thepost cavity to form the tip; inserting the pin with a distal end of thebody; disposing the distal end of the body and the pin into the moldcavity such that the post is disposed with the post cavity and, the postcavity defining a non-perpendicular transition configuration extendingto engage a wall of the post cavity; injecting a material into the moldcavity to simultaneously mold the tip with the distal end of the body,and to mold a lateral opening with the tip in relation to thepredetermined transition configuration such that the lateral opening isdefined by a wall including an external radius disposed in transitionwith an outer surface of the tip and an internal radius disposed intransition with an inner surface of the tip, the external radius havinga non-perpendicular profile with the outer surface of the tip; removingthe body and the pin from the mold cavity; and removing the pin from thecatheter through the lateral opening. Alternatively, the method mayinclude the step of mounting an expandable member about the body and thetip.

In alternate embodiment, the method includes the steps of providing amold assembly that includes a mold cavity, the mold assembly having aremovable spring block that forms a portion of the mold cavity anddefines a post cavity that communicates with the mold cavity, the postcavity defining a non-perpendicular transition configuration; providinga pin having a core and a post extending therefrom, the post cooperatingwith the non-perpendicular transition configuration to form the tip;inserting the core with a distal end of the body; disposing the distalend of the body and the pin with the mold cavity such that the core isspaced apart from walls of the mold cavity and the post is disposed withthe post cavity and extends to engage a wall of the post cavity;injecting a silicone based material into the mold cavity tosimultaneously mold the tip with the distal end of the body such thatthe tip defines a central lumen, and to mold a lateral opening with thetip in relation to the non-perpendicular transition such that thelateral opening is defined by a wall including an external radiusdisposed in transition with an outer surface of the tip and an internalradius disposed in transition with an inner surface of the tip, theexternal radius having a non-perpendicular profile with the outersurface of the tip and the internal radius having a non-perpendicularprofile with the inner surface of the tip; removing the body and thespring block, having the pin disposed therewith, from the mold cavity;removing the pin from the tip through the lateral opening; and mountingan expandable sleeve about the body and the tip.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and features of the present disclosure, which are believedto be novel, are set forth with particularity in the appended claims.The present disclosure, both as to its organization and manner ofoperation, together with further objectives and advantages, may be bestunderstood by reference to the following description, taken inconnection with the accompanying drawings, as set forth below.

FIG. 1 is a plan view of a distal portion of the urology catheter inaccordance with the principles of the present disclosure;

FIG. 2 is a cross-sectional view of the urology catheter shown in FIG.1;

FIG. 3 is a cutaway cross-sectional view of the urology catheter takenalong lines 3-3 shown in FIG. 1;

FIG. 3A is a cutaway perspective view of the urology catheter takenalong lines 3A-3A shown in FIG. 1;

FIG. 3B is a cutaway perspective view of a lateral opening of theurology catheter shown in FIG. 1;

FIG. 4 is a cutaway side view of the urology catheter shown in FIG. 1,illustrating lumens in phantom;

FIG. 5 is a cutaway cross-sectional side view of the urology cathetershown in FIG. 1;

FIG. 6 is a perspective view of a mold assembly, with a section removed,in accordance with the principles of the present disclosure;

FIG. 7 is a perspective view of a spring block assembly shown in FIG. 6;

FIG. 8 is a cutaway side perspective view of a pin shown in FIG. 6;

FIG. 9 is a side view of the pin shown in FIG. 6;

FIG. 10 is an alternate side cross-sectional view taken along lines10-10 shown in FIG. 9 of the pin, in part elevation;

FIG. 11 is a side cross-sectional view of a spring block shown in FIG.6;

FIG. 12 is a side cross-sectional view of the indicated area of detailshown in FIG. 11;

FIG. 13 is a side cross-sectional view of the spring block assemblyshown in FIG. 6, illustrating the pin in part elevation;

FIG. 14 is a perspective view of the mold assembly, with a catheterdisposed therewith;

FIG. 15 is a perspective view of the mold assembly and the cathetershown in FIG. 14, with a section removed;

FIG. 16 is a cutaway perspective view of a proximal end of an alternateembodiment of the urology catheter shown in FIG. 1; and

FIG. 17 is a cutaway side cross-sectional view of the proximal end ofthe urology catheter shown in FIG. 16.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The exemplary embodiments of the urology catheter and methods of usedisclosed are discussed in terms of medical catheters for theadministration of fluids (withdrawal, introduction, and otherprocedures) with the body of a subject and more particularly, in termsof a urology catheter including an advantageous tip configuration andrelated method of manufacture that improves drainage characteristics andenhances stiffness to facilitate tip insertion with a patient. Theurology catheter can include molded openings, tip and shaft members thatmay be fabricated from a variety of different materials having varyingdurometer and flexibility characteristics. It is contemplated that thecatheter can be used for various applications for the administration offluids such as, for example, surgical, diagnostic and related treatmentsof diseases, and body ailments of a subject. It is further contemplatedthat the principles relating to the catheter disclosed includeemployment with various catheter related procedures, such as, forexample, abdominal, urinary and intestinal applications. It isenvisioned that the catheter can be used for administration of fluidssuch as, for example, the introduction of medication and saline, andwithdrawal of fluids such as, blood, urine, and other bodily fluids.

In the discussion that follows, the term “proximal” will refer to theportion of a structure that is closer to a practitioner, while the term“distal” will refer to the portion that is further from thepractitioner. As used herein, the term “subject” refers to a humanpatient or other animal. According to the present disclosure, the term“practitioner” refers to a doctor, nurse or other care provider and mayinclude support personnel.

The following discussion includes a description of a urology catheter,in accordance with the principles of the present disclosure. Referencewill now be made in detail to the exemplary embodiments of thedisclosure, which are illustrated in the accompanying figures.

Turning now to the figures, wherein like components are designated bylike reference numerals throughout the several views. Referringinitially to FIGS. 1-5, a urology catheter 20 includes an elongated body22 defining a longitudinal axis x. Body 22 is tubular and extends from aproximal end (not shown) to a distal end 26. It is contemplated thatbody 22 may be variously dimensioned and attachable to other medicaldevices. For example, catheter 20 may be variously sized such as 12, 16,18 and 26 French. It is further contemplated that the outer surface ofbody 22 may have various configurations, such as, for example,rectangular, elliptical, polygonal, etc.

Distal end 26 defines a planar face 28 that has a substantiallyperpendicular orientation relative to longitudinal axis x. Planar face28 is disposed along a plane y for attachment with a tip, as will bediscussed. It is envisioned that planar face 28 may alternatively bedisposed in various angular orientations relative to longitudinal axisx, such as acute and obtuse.

Body 22 defines a first lumen, such as, for example, drainage lumen 30and a second lumen, such as, for example, inflation lumen 32. Drainagelumen 30 is configured for fluid flow and in communication with theproximal end of catheter 20 for drainage of urine from a bladder of asubject (not shown). The proximal end of catheter 20 is connected to areceptacle (not shown) for collection of the urine.

Inflation lumen 32 is configured for fluid and/or gas flow to inflate anexpandable member, as will be discussed. Inflation lumen 32 is disposedadjacent distal end 26 of body 22 and includes a port 33 for fluidconnection with the expandable member. Lumens 30, 32 may be uniformlydimensioned or include alternative dimensional cross sections withinbody 22, such as, narrow and broad portions, converging surfaces,undulating surfaces, etc. according to the particular flow indicationsand/or flow rate requirements. It is contemplated lumens 30, 32 mayextend uniform or alternative lengths. It is further contemplated thatbody 22 may include one or a plurality of lumens.

A flexible tubular tip 34 is configured for insertion with the urethraof a subject and disposal within the bladder. Tip 34 has a flexiblecurved body and a cylindrical head 35. Tip 34 has a proximal end 36 thatdefines a planar face 38. Planar face 38 of tip 34 is disposed inabutting relation with planar face 28 of body 22 such that body 22 issecured with tip 34. Planar face 38 has a substantially perpendicularorientation relative to longitudinal axis x, Planar face 38 is disposedalong plane y for attachment with planar face 28 of body 22, as will bediscussed. It is envisioned that planar face 38 may alternatively bedisposed in various angular orientations relative to longitudinal axisx, such as acute and obtuse. It is contemplated that tip 34 may beuniformly aligned with longitudinal axis x or alternatively have varyingdegrees of curvature. It is further contemplated that tip 34 may beemployed with a guide wire or stylet. Head 35 may have alternativegeometric configurations according to the requirements of a particularapplication.

Tip 34 defines a central lumen 40 that is in fluid communication withdrainage lumen 30 for drainage of urine from the bladder. Tip 34 has alateral opening, such as, for example, drain eye 42 that communicateswith central lumen 40 and is configured for disposal within the bladderfor urine drainage.

Referring to FIGS. 3, 3A and 3B, drain eye 42 is defined in a wall 44 oftip 34. The opening of drain eye 42 is defined by a surface 45 that isdisposed about the perimeter of drain eye 42. Surface 45 has a radius ofcurvature R about the perimeter of drain eye 42. Radius of curvature Rincludes an external radii and an internal radii relative to wall 44,with a chamfer surface 43 disposed therebetween. Chamfer 43 may bevariously dimensioned and oriented, such as, for example, 0.010 inchthickness by 45 degree inclination relative to a plane defined by wall44, 0.030 inch thickness by 30 degree inclination, 0.015 inch thicknessby 45 degree inclination, 0.025 inch thickness by 55 degree inclinationas well as other dimensions and orientations according to therequirements of a particular application.

Radius of curvature R includes an external radii R_(e1) and R_(e2),which are disposed in transition with an outer surface 46 of tip 34.Radius R_(e1) is disposed adjacent a distal end of drain eye 42 andR_(e2) is disposed adjacent a proximal end of drain eye 42. Externalradii R_(e1) and R_(e2) have a non-perpendicular profile with outersurface 46. External radii R_(e1) and R_(e2) may uniformly oralternatively be perpendicularly disposed, non-perpendicularly disposedor disposed at various radial orientations relative to outer surface 46of tip 34. External radii R_(e1) and R_(e2) may be variouslydimensioned, such as, for example, in the range of 0.005-0.080 inchradius as well as other dimensions according to the requirements of aparticular application.

Radius of curvature R also includes an internal radii Ri₁ and Ri₂, whichare disposed in transition with an inner surface 48 of tip 34. RadiusRi₁ is disposed adjacent a distal end of drain eye 42 and Ri₂ isdisposed adjacent a proximal end of drain eye 42. Internal radii Ri_(i)and Ri₂ are disposed in a substantially perpendicular profile with innersurface 48. Internal radii Ri₁ and Ri₂ may uniformly or alternatively beperpendicularly disposed, non-perpendicularly disposed or disposed atvarious radial orientations relative to inner surface 48 of tip 34.Internal radii Ri₁ and Ri₂ may be variously dimensioned, such as, forexample, in the range of 0.005-0.080 inch radius as well as otherdimensions according to the requirements of a particular application.

Radius of curvature R also includes an external radii R_(e3) and R_(e4),which are disposed in transition with outer surface 46 of tip 34.External radii R_(e3) and R_(e4) are disposed adjacent side portions ofdrain eye 42. External radii R_(e3) and R_(e4) have a non-perpendicularprofile with outer surface 46. External radii R_(e3) and R_(e4) mayuniformly or alternatively be perpendicularly disposed,non-perpendicularly disposed or disposed at various radial orientationsrelative to outer surface 46 of tip 34. External radii R_(e3) and R_(e4)may be variously dimensioned, such as, for example, in the range of0.005-0.080 inch radius as well as other dimensions according to therequirements of a particular application.

Radius of curvature R also includes an internal radii R_(i3) and R_(i4),which are disposed in transition with inner surface 48 of tip 34.Internal radii R_(i3) and R_(i4) are disposed adjacent side portions ofdrain eye 42. Internal radii R_(i3) and R_(i4) have a non-perpendicularprofile with inner surface 48. Internal radii R_(i3) and R_(i4) mayuniformly or alternatively be perpendicularly disposed,non-perpendicularly disposed or disposed at various radial orientationsrelative to inner surface 48 of tip 34. Internal radii R_(i3) and R_(i4)may be variously dimensioned, such as, for example, in the range of0.005-0.080 inch radius as well as other dimensions according to therequirements of a particular application.

This configuration of drain eye 42 advantageously improves drainagecharacteristics of catheter 20, avoids encrustation during use andenhances stiffness to facilitate tip 34 insertion with a subject. Draineye 42 optimizes central lumen 40 area to improve fluid flow. Thegeometry of drain eye 42, including the radii and chamfer discussed,provides a smooth transition about its perimeter, which facilitates alaminar flow of fluids exiting drain eye 42. The laminar flow preventsbacteria buildup and the formation of a bacteria film or the like aboutdrain eye 42.

Tip 34 has enhanced stiffness to facilitate manipulation due to theimproved flow characteristics of drain eye 42, which avoids thenecessity for an oversized drain eye. Accordingly, the wall thickness oftip 34 can be optimized for stiffness. It is contemplated that thestiffness of tip 34 may be further enhanced by material selection. It isenvisioned that drain eye 42 may be defined by a wall having taperededges. It is envisioned that tip 34 may include one or a plurality ofopenings.

An expandable member, such as, for example, cuff 50 has a proximalsecuring portion 52 and a distal securing portion 54. Cuff 50 isdisposed along catheter 20 and, overlaps body 22 and tip 34 adjacent aregion of fixation, such as, for example, an abutment region 56.Proximal securing portion 52 is disposed about body 22 and securedthereto, as will be discussed. Distal securing portion 54 is disposedabout tip 34. Distal securing portion 54 of cuff 50 is bonded overabutment region 56 of body 22 and tip 34, an example of which beingdescribed in accordance with a method of manufacture discussed herein.This configuration advantageously provides a more secure and stable tip34, while removing any visual flash or mismatch from catheter 20. It isenvisioned that distal securing portion 54 may be adhesively bonded overa region of fixation between body 22 and tip 34.

Cuff 50 defines an inflation cavity 58 with an outer surface 60 of body22 that is in fluid communication with inflation lumen 32. Inflationcavity 58 connects with port 33 to facilitate fluid connection withinflation lumen 32. Inflation lumen 32 is configured for fluid flow toinflate cuff 50. Cuff 50 is configured for expansion to retain catheter20 within the bladder and may include a balloon or similar configurationto facilitate retention. A cross sectional area 62 of central lumen 40is advantageously greater than a cross sectional area 64 of first lumen30. This configuration advantageously improves the drainagecharacteristics of catheter 20. It is contemplated that an expansiondevice, such as, for example an onion or the like, is disposed withinbody 22 adjacent cuff 50. It is further contemplated that an innersurface of cuff 50 may include one or plurality of ribs.

Desirably, body 22 and tip 34 are fabricated from a silicone basedmaterial having sufficient flexibility and stiffness for disposal withina body cavity. Silicone rubbers or other non-reactive, biologicallyinert or bio-compatible rubbers, latex, or the like are contemplated.The components of catheter 20 may be fabricated from materials suitablefor medical applications, such as, for example, polymerics or metals,such as stainless steel, depending on the particular application and/orpreference of a practitioner. Semi-rigid and rigid polymerics arecontemplated for fabrication, as well as resilient materials, such asmolded medical grade polypropylene. One skilled in the art, however,will realize that other materials and fabrication methods suitable forassembly and manufacture, in accordance with the present disclosure,also would be appropriate.

It is contemplated herein that catheter 20 of the present disclosure maybe fabricated and incorporate various materials having differentcompounds, flexibility and durometer for each respective part, forexample, body 22, tip 34 and cuff 50 may be formed from the same ordifferent materials and formed from molding, extrusion or the like.

Referring to FIGS. 6-15, a method of manufacturing a catheter, similarto urological catheter 20 having body 22 and tip 34 is described, inaccordance with the principles of the present disclosure. Tip 34 ismolded directly onto distal end 26 of body 22, such that tip 34 isconnected to body 22 without the use of adhesive.

A mold assembly 100 has a mold block 102 that includes a mold cavity104. Mold assembly 100 has a removable spring block 106, as shown inFIG. 7, that forms a portion of mold cavity 104. Spring block 106defines a post cavity 108, as shown in FIGS. 11 and 12, thatcommunicates with mold cavity 104. Post cavity 108 defines apredetermined transition, such as, for example, non-perpendiculartransition configuration 110 that facilitates formation of radius ofcurvature R of drain eye 42. A pin 112, as shown in FIGS. 9 and 10, hasa core 114 and a post 116 extending therefrom. Post 116 cooperates withnon-perpendicular transition configuration 110 to form tip 34. Pin 112also cooperates with spring block 106 to form drain eye 42. For example,as shown in FIG. 8, surfaces 118 of post 116 cooperate with spring block106 to form external radii R_(e1) and R_(e2), and internal radii Ri₁|and Ri₂. Surfaces 120 of post 116 cooperate with non-perpendiculartransition configuration 110 to form external radii R_(e3) and R_(e4),and internal radii R_(i3) and R_(i4). It is contemplated thatpredetermined transition may be variously configured such as, forexample perpendicular or disposed at various radial orientationsaccording to the requirements of a particular application.

A body 22, similar to that described above, is provided that extendsfrom a proximal end (not shown) to distal end 26. Distal end 26 definesplanar face 28 that is disposed along plane y for abutting connectionwith the tip to be formed. Core 114 of pin 112 is inserted with distalend 26 of body 22 thereby closing a distal end of drainage lumen 30.Distal end 26 of body 22 and pin 112 are disposed with mold cavity 104such that core 114 of pin 112 is spaced apart from walls 122 of moldcavity 104. Post 116 of pin 112 is disposed with post cavity 108 andextends to engage a wall 124 of post cavity 108, as shown in FIG. 13.Distal end 26 of body 22 is disposed in a channel 126 of mold cavity 104and body 22 extends out of block 102, as shown in FIG. 14. Thisconfiguration facilitates closure of a proximal end of mold cavity 104.

A molten silicone based material is injected into mold cavity 104 viagates 128, 130, as is known, to injection mold tip 34. This moltensilicone based material is injected into mold cavity 104 tosimultaneously mold tip 34 with distal end 26 of body 22 such that tip34 defines central lumen 40, and to mold drain eye 42 with tip 34 inrelation to the non-perpendicular transition configuration 110.Accordingly, drain eye 42 is defined by a wall 44, which includesexternal radii R_(e3) and R_(e4) disposed in transition with outersurface 46 of tip 34 and internal radii R_(i3) and R_(i4) disposed intransition with inner surface 48 of tip 34. External radii R_(e3) andR_(e4) have a non-perpendicular profile with outer surface 46 andinternal radii R_(i3) and R_(i4) also have a non-perpendicular profilewith inner surface 48. External radii R_(e1) and R_(e2), and internalradii Ri₁ and Ri₂ are also formed simultaneously. Tip 34 is formed withplanar face 38 for direct connection and abutment with planar face 28 ofbody 22. Cylindrical head 35 is also formed. Other molten materials arecontemplated for injection molding.

After tip 34 has sufficiently cured, spring block 106, having pin 112disposed therewith, and body 22 are removed from mold cavity 104. Body22, having tip 34 molded thereto, and pin 112 disposed therein, areremoved from spring block 106. Pin 112 is removed from tip 34 throughdrain eye 42. Core 114 of pin 112 is disposed in central lumen 40 andpost 116 extends through drain eye 42. Tip 34 is flexed slightly tomanipulate the distal end of tip 34 over the distal end of pin 112. Theremaining portion of core 114 is drawn through drain eye 42 from centrallumen 40 and consequently out of tip 34. A source of pressurized gas maybe connected to body 22 to blow catheter 20 off pin 112. Thus, tip 34 isadvantageously directly molded to body 22 adjacent an abutment region 56of catheter 20 while forming central lumen 40 and drainage eye 42.

Cuff 50 is mounted about body 22 and tip 34. Proximal securing portion52 of cuff 50 is bonded to body 22 at a zone 132 (FIG. 2) adjacentdistal end 26. Distal securing portion 54 of cuff 50 is bonded overabutment region 56 of body 22 and tip 34. Cuff 50 overlaps body 22 andtip 34 to form inflation cavity 58 with outer surface 60 of body 22.Cuff 50 is connected with port 33 to establish communication withinflation lumen 32. Proximal securing portion 52 and distal securingportion 54 may be adhesively bonded to body 22 and tip 34, or attachedalternatively by clips, staples or other bonding techniques.

Referring to FIGS. 16 and 17, an alternate embodiment of catheter 20,similar to that described above, is shown. Catheter 20 includes aproximal end 224 that is attached to a connector 226. Connector 226includes an adapter 228 that communicates with drainage lumen 30.Adapter 228 is configured for connection to a drainage receptacle (notshown) for urine collection. Connector 226 also includes an arm 230 thatcommunicates with inflation lumen 32. Arm 230 is configured forconnection to a inflation fluid/gas source.

Connector 226 includes a projection, such as, for example, bump 232 thatis configured to provide visual indicia and tactile indicia of theorientation of tip 34 when disposed with the subject. For example,catheter 20 can be rotated to orient tip 34 through a body cavity duringuse. A practitioner manipulating catheter 20 can determine orientationof tip 34 according to the tactile feel provided by bump 232.Alternatively, body 22 may be fabricated from a material having a firstindicia of color, and bump 232 may be fabricated from a material havinga second indicia of color. In use, the practitioner can determineorientation of tip 34 according to orientation and corresponding visualrepresentation provided by bump 232 due to the distinction in color ofbody 22 and the color of bump 232. It is contemplated that proximal end224 and/or bump 232 may be fabricated in an injection molding stepseparate from the injection molding fabrication of body 22 and tip 34discussed above with regard to FIGS. 6-15.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A method of manufacturing a catheter having abody and a tip, the method comprising the steps of: providing a moldthat defines a mold cavity and a post cavity that communicates with themold cavity, the post cavity defining a predetermined transitionconfiguration; providing a pin having a post extending therefrom, thepost cooperating with the predetermined transition configuration of thepost cavity to form the tip; inserting the pin with a distal end of thebody; disposing the distal end of the body and the pin into the moldcavity such that the post is disposed with the post cavity and extendsto engage a wall of the post cavity; injecting a material into the moldcavity to simultaneously mold the tip with the distal end of the body,and to mold a lateral opening with the tip in relation to thepredetermined transition configuration such that the lateral opening isdefined by a wall including an external radius disposed in transitionwith an outer surface of the tip and an internal radius disposed intransition with an inner surface of the tip, the external radius havinga non-perpendicular profile with the outer surface of the tip; removingthe body and the pin from the mold cavity; and removing the pin from thecatheter through the lateral opening.
 2. A method as recited in claim 1,wherein the mold includes a removable block that forms a portion of themold cavity and defines the post cavity.
 3. A method as recited in claim2, wherein the step of removing the body and the pin from the moldcavity further includes removing the block, having the pin disposedtherewith, from the mold.
 4. A method as recited in claim 1, wherein thestep of disposing includes disposing the pin with the mold cavity suchthat the pin is spaced apart from walls of the mold cavity.
 5. A methodas recited in claim 1, wherein the material includes a silicone basedrubber.
 6. A method as recited in claim 1, wherein the step of injectingincludes molding a tip that defines a central lumen in communicationwith the lateral opening.
 7. A method as recited in claim 1, furthercomprising the step of mounting an expandable member about the body andthe tip.
 8. A method of manufacturing a catheter having a body and atip, the method comprising the steps of: providing a mold assembly thatincludes a mold cavity, the mold assembly having a removable springblock that forms a portion of the mold cavity and defines a post cavitythat communicates with the mold cavity, the post cavity defining anon-perpendicular transition configuration; providing a pin having acore and a post extending therefrom, the post cooperating with thenon-perpendicular transition configuration to form the tip; insertingthe core with a distal end of the body; disposing the distal end of thebody and the pin with the mold cavity such that the core is spaced apartfrom walls of the mold cavity and the post is disposed with the postcavity and extends to engage a wall of the post cavity; injecting asilicone based material into the mold cavity to simultaneously mold thetip with the distal end of the body such that the tip defines a centrallumen, and to mold a lateral opening with the tip in relation to thenon-perpendicular transition configuration such that the lateral openingis defined by a wall including an external radius disposed in transitionwith an outer surface of the tip and an internal radius disposed intransition with an inner surface of the tip, the external radius havinga non-perpendicular profile with the outer surface of the tip and theinternal radius having a non-perpendicular profile with the innersurface of the tip; removing the body and the spring block, having thepin disposed therewith, from the mold cavity; removing the pin from thetip through the lateral opening; and mounting an expandable sleeve aboutthe body and the tip.